Update also revises economic modeling recommendations and requires disclosure of artificial intelligence use.
ALEXANDRIA, Va., Oct. 23, 2026 — The Academy of Managed Care Pharmacy (AMCP) has published Version 6.0 of the AMCP Format for Formulary Submissions, which guides how manufacturers present clinical and economic evidence to health plans, pharmacy benefit managers (PBMs), and other health care decision-makers. The update adds a streamlined submission framework for biosimilars, new guidance for cell and gene therapies (CGTs), and revised economic modeling recommendations. It appears in a supplement to the October 2026 Journal of Managed Care & Specialty Pharmacy (JMCP).
“The evidence landscape is changing rapidly, and the AMCP Format continues to evolve to help health care decision-makers assess new therapies with confidence,” said Susan Cantrell, MHL, RPh, CAE, CEO of AMCP. “By strengthening guidance for emerging therapies, economic modeling, and new technologies, Format 6.0 supports more informed decisions about the therapies patients need.”
Biosimilars. Version 6.0 replaces the full dossier with a structured submission table. The table covers interchangeability, differences in indications from the reference product, immunogenicity, cost by National Drug Code, and distribution model. Manufacturers must also show whether each study used the biosimilar or the reference biologic, so reviewers can see which indications rest on extrapolated evidence. The streamlined approach brings key information for biosimilar formulary decision-making together in one place while reducing the information manufacturers need to prepare.
Cell and gene therapies. These products are often approved on small, single-arm, or short-term studies. The Format asks manufacturers to describe durability of effect, required testing, site-of-care needs, and long-term monitoring. It also asks them to keep observed outcomes separate from projected or modeled effects. Economic analyses should state their assumptions and time horizons clearly. Health care decision-makers need this to evaluate durability claims for high-cost, often one-time treatments.
Economic modeling. Budget impact models should be editable, accept plan-specific inputs including negotiated prices or rebates, and report gross and net impact per member per month. Manufacturers that do not provide an interactive model must say so. These standards let payers test projections against their own populations and pricing.
Artificial intelligence. Dossier authors must disclose their use of AI, and a qualified individual must verify the content before the dossier is finalized.
The AMCP Format for Formulary Submissions Committee developed the update over two terms. The draft was open for public comment from March 17 to April 22, 2026, and drew comments from industry, payers, academia, consultants, and professional associations. Work is underway on the next update, planned for 2027. It will focus on three areas: modernizing the Format framework to keep pace with advances in technology, guidance on including real-world evidence and patient experience data, and further recommendations on the use of artificial intelligence in dossier development. As with Version 6.0, stakeholders will have an opportunity to comment on the draft before it is finalized.
The AMCP Format 6.0 is available on JMCP. Questions about the Format may be directed to Dana McCormick, Vice-President Practice Innovation & Business Strategies, at @email.
AMCP Media Contact
@email
About AMCP
AMCP is the professional association leading the way to help patients get the medications they need at a cost they can afford. AMCP’s diverse membership of pharmacists, physicians, nurses, biopharmaceutical professionals, and other stakeholders leverage their specialized expertise in clinical evidence and economics to optimize medication benefit design and population health management and help patients access cost-effective and safe medications and other drug therapies. AMCP members improve the lives of nearly 300 million Americans served by private and public health plans, pharmacy benefit management firms, and emerging care models.
AMCP offers a wide variety of educational opportunities, from events and webinars to online training.
